Job Description

About Us

ten23 health is a human-centric and sustainable strategic partner of choice for the pharmaceutical industry and biotech start-ups for the development, manufacture, and testing of tomorrow’s medicines. We support our clients in developing differentiated, stable, usable, and safe injectable treatments for patients.

Your mission

We are looking for an Experienced Qualification Engineer to play a defining role in our ambitious expansion in Visp. You won't just follow a checklist; you will lead the Commissioning, Qualification, and Validation (CQV) strategy for our brand-new, state-of-the-art greenfield manufacturing site. This is a rare opportunity to shape a facility from the ground up, ensuring it meets the highest standards of quality and patient safety.

Your responsibilities will include,

• As a Qualification Engineer you are responsible for defining CQV stratergy and independentlv planning & managing qualification projects for our new manufacturing site.
• According to our Q-System you will independently engage specialized external companies, supervise and check their assignments or depending on the project carry out qualifications by yourself in the phases DQ-IQ-OQ-PQ. You support FATs and SATs
• You are responsible for maintaining the qualified condition of the equipment and for planning and implementing necessary requalifications
• You perform periodic reviews
• You will be involved in the continuous development of our qualification concept, incorporating changes to applicable standards, guidelines and technical developments
• You represent your department during audits and inspections

Your profile

We are looking for someone with:

• Completed studies (Master's/Bachelor's degree) in mechanical engineering, pharmaceutical technology, medical technology, chemistry, process engineering or similar or completed technical or scientific training with suitable further training and subject-specific specialisation
• Sound knowledge and several years of experience in the field of plant qualification in a GMP surrounding
• Good understanding of GMP, good technical and bioprocess understanding, as well as quality and safety awareness.
• Work as a proactive "Fellow" alongside the Customer Delivery, QA, and IT Circles to ensure seamless technical integration and a culture of mutual trust and self-responsibility.

Why us?

We offer:

• A valuable and impactful career development opportunity in a inspiring environment
• Flexible working arrangements and environment with an open culture and diverse workforce
• The opportunity to work with and learn from highly qualified and experienced employees
• Our learning and self-developing culture offers a wide range of training options
• Competitive pension fund plan, annual bonus, and other financial and non-financial benefit

At ten23 we believe in self-responsibility and mutual trust. Therefore, we will provide our employees as much flexibility as possible and limit any bureaucracy to a minimum, whilst ensuring compliance with all applicable laws.

Contact

For more information and clarification, please connect Amrith (amrith.kiran@ten23.health) from our Talent team!